NDA Submitted for Tivozanib for Advanced Renal Cell Carcinoma

AVEO and Astellas announced that AVEO has submitted a New Drug Application (NDA) to the FDA seeking approval for tivozanib in patients with advanced renal cell carcinoma (RCC).

The NDA submission is based on results of the global Phase 3 TIVO-1 (Tivozanib Versus Sorafenib in 1st line Advanced RCC) trial, a randomized superiority-designed pivotal trial evaluating the efficacy and safety of tivozanib compared to sorafenib (Nexavar; Bayer and Onyx) in 517 patients with advanced RCC who had no prior treatment with a systemic therapy, as well as data from 17 clinical studies involving over 1,000 subjects who received tivozanib. In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival (PFS) vs. sorafenib, an approved targeted agent, and a favorable tolerability profile.

Tivozanib is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors that is designed to optimize VEGF blockade while minimizing off target toxicities.